EDF Health

Selected tag(s): Significant New Use Rule (SNUR)

Too little, too fast: EDF comments raise numerous concerns with EPA’s proposal to expand use of a toxic chemical

Richard Denison, Ph.D.is a Lead Senior Scientist.

Last month EDF blogged about  our request to the Environmental Protection Agency (EPA) to extend the illegally and unreasonably short 15-day comment period it had provided on a modification EPA is proposing to make to expand the ways a toxic chemical could be used, subject to certain conditions, without triggering any requirement to first notify EPA.  Specifically, EPA is proposing to modify the Significant New Use Rule (SNUR) applicable to the chemical – which currently limits its use to metalworking fluid – to allow the chemical also to be used as an anti-corrosive agent in in oilfield operations and hydraulic fluids.

Our request  also noted that EPA had failed to provide the public with anything approaching a complete set of documents relevant to its proposal.  For example, the public docket for the proposed modified SNUR lacked even a redacted copy of the Significant New Use Notice (SNUN) that triggered EPA’s consideration of the expanded use.

EPA’s proposal to amend the SNUR noted that, while EPA was expanding the allowable uses of the chemical, it was also proposing to impose additional conditions on the use.  These conditions were necessary, EPA argued, because of “test data on the substance and on new data regarding the expected release of formaldehyde from the substance, for skin and eye irritation, neurotoxicity, mutagenicity, oncogenicity, allergic responses, and developmental toxicity.”

Yet the docket did not include copies of these health and safety studies or the test data, despite being referred to in the proposal and in other documents that are in the docket.  As a reminder, such health and safety studies and their underlying data must be made public under the Toxic Substances Control Act (TSCA).  And of course, access to them is crucial if the public is expected to comment on EPA’s proposal.

A few days before the end of the 15-day comment period, EPA did grant a 17-day extension.  It also added a copy of the SNUN to the docket.  But it failed to add any of the health and safety studies or associated data we had identified as missing.

The comment period ended yesterday, and despite the serious time constraint and information gaps, EDF filed these extensive comments last night.  In preparing our comments, however, we found that the amount of health and safety data EPA had failed to provide is even greater than we had originally thought.  And our concerns over the adequacy of EPA’s review of this new proposed use and of the conditions it proposes to include in the modified SNUR have only grown.   Read More »

Posted in EPA, Health Policy, TSCA Reform / Also tagged | Comments are closed

EDF requests extension of illegally and unreasonably short comment period on proposed rule with incomplete docket

Richard Denison, Ph.D.is a Lead Senior Scientist.

Environmental Defense Fund (EDF) today submitted a request to the Environmental Protection Agency (EPA) to extend the mere 15-day period EPA has provided for public comments on a proposed modification to a Significant New Use Rule (SNUR).  The proposed SNUR modification was published in the Federal Register just last Thursday (February 8), and stated that comments must be received by February 23.

EPA must comply with its own requirements and provide electronic access to a public file containing all relevant documents prior to commencing at a minimum a 30-day comment period on this proposed rule.

EPA’s own regulations require EPA to provide the public with at least 30 days to comment on SNURs, see 40 CFR 721.160(c)(4) and 721.170(d)(4), making EPA’s 15-day comment period illegally short.

EDF requested that EPA provide at least 30 days for public comment – with that period to commence only after a complete public docket of relevant materials is made available by EPA.  As our request details, the docket EPA has provided for this proposed SNUR is woefully incomplete, missing even basic documents that preclude the public from being able to provide meaningful comments on the proposal.   Read More »

Posted in EPA, Health Policy, Regulation, TSCA Reform / Also tagged , | Comments are closed

EDF files extensive comments challenging EPA’s changes to new chemical reviews under TSCA

Richard Denison, Ph.D.is a Lead Senior Scientist.

This weekend EDF submitted detailed comments to the Environmental Protection Agency (EPA) on its implementation of changes to the New Chemicals Review Program, as well as comments responding to the agency’s draft New Chemicals Decision‐Making Framework.

After the passage of the Lautenberg Act in June 2016, EPA started out on a sound footing in implementing the major changes to Section 5 of the Toxic Substances Control Act (TSCA), correctly subjecting more new chemicals to conditions or testing requirements through issuance of consent orders.  It also took successful steps to address a temporary backlog that was largely due to the fact that these changes to TSCA took immediate effect.

Beginning in August of last year, however, using the already eliminated backlog as an excuse, the new political leadership at EPA signaled its intent to reverse course and effectively return the program to its pre-Lautenberg state – under which few chemicals were subject to any conditions and even fewer to any testing requirements, despite the fact that the great majority of new chemicals reviewed by EPA lack any health or environmental safety data.

EPA convened a meeting in early December of last year to present its New Chemicals Decision‐Making Framework implementing these changes.  The agency noted it was already using the Framework, despite also accepting comments on it.

EDF’s comments raise a host of legal, policy, scientific, good government and transparency objections to EPA’s new approach.  I won’t attempt to summarize the 42 pages of our comments here, many aspects of which we have raised through this blog over the past many months.

We hope EPA reconsiders its rash change of course and opts to comply with the law.

 

Posted in EPA, Health Policy, TSCA Reform / Also tagged , | Comments are closed

EDF comments at EPA’s public meeting on new chemical reviews question the credibility and legality of recent changes

Richard Denison, Ph.D.is a Lead Senior Scientist.

EPA held a public meeting today to present information on major changes it is making to its review of new chemicals under last year’s reforms made to the Toxic Substances Control Act (TSCA) by the Lautenberg Act.

EPA provided brief opportunities for stakeholders to provide comments.  Two of us from EDF – I, and my colleague Robert Stockman, Senior Attorney – gave oral comments at the meeting.  We are providing those comments here in written form.

Through these actions, many clearly contrary to the law, EPA is returning the new chemicals program to its dark ages under the old TSCA, making it again into a black box within which EPA acts as if its only stakeholder is the chemical industry.

My comments are available here.

Robert Stockman’s comments are available here.

As the comments make clear, EDF believes the changes EPA is making and discussed today are both contrary to the requirements of the new TSCA and represent a retreat from the credible, transparent and accountable new chemicals program Congress sought to establish under the new law.

As I noted in my comments:  “Through these actions, many clearly contrary to the law, EPA is returning the new chemicals program to its dark ages under the old TSCA, making it again into a black box within which EPA acts as if its only stakeholder is the chemical industry.”

Posted in EPA, Health Policy, Industry Influence, Regulation, TSCA Reform / Also tagged , | Comments are closed

Too little, too late: Why SNURs alone are not a sufficient alternative to consent orders for new chemicals

Richard Denison, Ph.D.is a Lead Senior Scientist.

The Environmental Protection Agency (EPA) is in the process of making some major changes to its policies and practices governing new chemical reviews.  This post discusses one of the most troubling ones.  

The SNUR-only approach EPA is now deploying differs dramatically from and provides far less risk protection than would result from it simply doing what the law requires:  using orders, with SNURs as backup.

As I have previously described, last year’s Lautenberg Act made extensive changes to section 5 of the Toxic Substances Control Act (TSCA), which governs the review of new chemicals prior to their manufacture and use.  Among these changes is a requirement that EPA must evaluate potential risks, and mitigate potential unreasonable risks, of a new chemical under its “conditions of use,” which the new law defines to include “reasonably foreseen” circumstances of production, processing, distribution, use or disposal, as well as those intended by the company submitting notice of the new chemical to EPA.  If EPA identifies potential risk or significant exposure or lacks sufficient information on a new chemical, it must issue an order prohibiting or limiting the conditions of use of the chemical in order to mitigate any unreasonable risk.

After passage of the Lautenberg Act until recently, and in keeping with the new law, if EPA’s review identified risk concerns relating to conditions of use beyond those strictly identified by a company submitting a new chemical notice to EPA, the agency made a “may present an unreasonable risk” finding and pursued development of a consent order with the company sufficient to ameliorate those concerns.  (While EPA has authority to issue unilateral orders, it typically negotiates with the company to arrive at a consent order that both parties sign.)

Now EPA is indicating it will instead make a “not likely to present an unreasonable risk” finding for the intended conditions of use, and says it can address any concerns over reasonably foreseen uses without issuing an order by developing only a significant new use rule (SNUR).  This “SNUR-only approach” is inconsistent with the law, a matter I won’t discuss further here.  However, it also raises a host of policy concerns, some of which I lay out in this post.

The SNUR-only approach EPA is now deploying differs dramatically from and provides far less risk protection than would result from it simply doing what the law requires:  using orders, with SNURs as backup.

There are ample reasons why Congress called on EPA to use orders to address concerns and then use SNURs as backup:  Orders (including consent orders) and SNURs are not created equal.  This post discusses 12 key differences, with respect to:

(Spoiler alert:  Deep dive ahead. Let me apologize to and warn readers in advance that this post gets rather into the weeds, as the issues are complicated and the details are important.)   Read More »

Posted in EPA, Health Policy, Regulation, TSCA Reform / Also tagged , | Comments are closed

EPA moves one step closer to managing risks from TCE

Lindsay McCormick is a Research Analyst.

It’s no secret that trichloroethylene (TCE) is a nasty chemical.  A 2013 review of thousands of scientific studies by Environmental Protection Agency (EPA) scientists concluded that TCE is carcinogenic to humans by all routes of exposure and poses additional hazards, including immunotoxicity, neurotoxicity, and adverse effects on the developing heart.  TCE’s link to cancer has been confirmed by the International Agency for Research on Cancer (IARC), EPA’s Integrated Risk Information System (IRIS),  the Agency for Toxic Substances and Disease Registry (ATSDR), and the National Toxicology Program (NTP).

With such a track record, one would expect that the U.S. government has restricted its use, right?  Wrong.  The current annual U.S. production of TCE is 250 million pounds – so, not surprisingly, human and environmental exposure is widespread.  While most TCE is used in industrial and commercial settings as a chemical intermediate in the production of other chemicals, it’s also commonly used as a metal degreasing agent and spot cleaner in commercial dry cleaning, and can be found in certain consumer products. Read More »

Posted in EPA, Health Policy, Regulation / Also tagged | Comments are closed